从质量控制发展趋势看药品技术监督

Understand the Technical Supervison of Drug from the Development Trends of Drug Quality Control

目的从药品质量控制发展趋势看药品技术监督的重要性。方法分析了药品质量控制的发展趋势以及药品技术监督所面临的新课题。结果保证药品安全、有效、质量可控,是药品研发和评价应遵循的基本原则,而质量的稳定可控是保证药品安全有效的基础和前提。结论只有把握药品发展的内在规律,认清其发展方向,才能做好药品技术监督工作。

Objective To understand importment of drug technical supervision from the development trend of drug quality control. Methods The new trends of drug quality and the new topic of technical supervison of drug products were analyzed. Results To ensure safe, effective and quality control of drugs is the basic principles followed a pharmaceutical research, development and evaluation, and stability and control of quality are the foundation and prerequisite ensured safe and effective of drug. Conclusions We can do a good job for the drug technical supervison when the developing trends and intrinsic pattern of drug quality were comprehended.